Published: 3 September 2020

Publications

Importing unapproved medicines for supply

Published: 3 September 2020
Prescriber Update 41(3): 58–59
September 2020

Importing medicines into New Zealand

The Medicines Act 1981 (the Act) places tight controls over the medicine supply chain through a system of licences to manufacture, sell, supply, pack, possess or administer medicines. These controls mean that prescribers and patients can be assured that approved medicines imported through the licensed supply chain are legitimate and have appropriate quality, safety and efficacy.

However, wholesalers, hospital and community pharmacies may import unapproved medicines for further supply in response to a prescription from a medical practitioner (section 29 of the Act).¹ Also, in some instances, authorised prescribers may directly import medicines for patients in their care (section 25 of the Act).¹ These less frequent importations of medicines are usually due to the lack of an approved product available in New Zealand.

Risks of importing and supplying unapproved medicines

Unapproved medicines imported into New Zealand have not gone through the usual medicine approval process in New Zealand and may not meet internationally agreed standards for quality, safety and efficacy. The risk of inadvertently importing a falsified or substandard medicine is also increasing as global supply chains become more complex and e-commerce spreads.²

Importers and prescribers of unapproved medicines are responsible for ensuring that they are appropriate in terms of quality, safety and efficacy.

How can importers reduce the risk of importing a falsified or substandard medicine?

Some simple checks can help, such as:

• check that the specification of these products meets international guidelines, for example, pharmacopoeia
• check whether a reputable overseas regulator has approved the products
• source the medicine from reputable, legitimate suppliers
• ask for information on the supply chain and storage conditions through the supply chain
• visually inspect the medicines received
• compare new stock to old stock for likeness and consistency of labelling
• check any patient information leaflets and product labelling for spelling and grammar
• have a documented procedure in place which describes how these checks are completed.

Any suspicion of counterfeit or poor-quality medicine should be immediately reported to Medsafe: recalls@health.govt.nz

Legal requirements for import and supply of unapproved medicines

Importers of any medicine must meet their legal obligations specified under section 42 of the Act.¹ Anyone importing a medicine, including authorised prescribers and medical practitioners, must obtain details of the specifications for testing the quality of that medicine and a certificate of the results of testing for every batch of that medicine. These details are usually in the ‘Certificates of Analysis’ or ‘COA’, which importers can request from the exporter. Under the Act, officers can request a copy of the COAs at any time so importers should retain these in a safe place.

Importers supplying unapproved medicines under section 29 of the Act must provide information on the supply to Medsafe (the section 29 declaration/notification form is available on the Medsafe website). International regulatory bodies will notify Medsafe of falsified or counterfeit medicines or medicines with a suspected quality issue. If these medicines have been imported into New Zealand, Medsafe can take action to protect patients.

More information

• Supplying unapproved medicines – including the section 29 declaration/notification form
• Use of unapproved medicines and unapproved use of medicines

References

1. Medicines Act 1981. URL: legislation.govt.nz/act/public/1981/0118/69.0/DLM53790.html (accessed 1 August 2020).
2. World Health Organization. 2017. WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products. URL: apps.who.int/iris/bitstream/handle/10665/326708/9789241513425-eng.pdf (accessed 4 August 2020).